Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT01174667
Status:
UNKNOWN
Last Update Posted:
2010-08-04
First Post:
2010-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Massage of the Low Back Muscles Assessed With Ultrasound Scanning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009209', 'term': 'Myofascial Pain Syndromes'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-08-03', 'studyFirstSubmitDate': '2010-08-02', 'studyFirstSubmitQcDate': '2010-08-03', 'lastUpdatePostDateStruct': {'date': '2010-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thickness of lumbodorsal fascia determined by ultrasound imaging', 'timeFrame': 'An average of 5 minutes from the the end of first treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Myofascial pain', 'Trigger points'], 'conditions': ['Myofascial Pain Syndrome']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to use diagnostic ultrasound to compare the thickness of soft tissues in the low back in a group of patients with chronic low back pain treated with massage to a control group of non-treated patients.\n\nIt is hypothesized that on average, soft tissue thickness in the lumbar region will change in the group receiving massage compared to the control group.', 'detailedDescription': 'A specialized form of massage designed to reduce fascial restrictions will be compared to a no-treatment control group based on a change in thickness of the lumbodorsal fascia as determined by ultrasound imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of chronic low back pain far at least 3 months\n* Able to read and write English\n* Between 18-64 years of age\n\nExclusion Criteria:\n\n* Prior lumbar surgery\n* Infected or broken skin over the lumbodorsal fascia\n* Major structural spinal deformity\n* Specific cause of low back pain, such as tumor, infection, fracture\n* Bleeding disorders or use of anticoagulant medications\n* Pregnancy\n* Litigation for low back pain\n* Systemic infection'}, 'identificationModule': {'nctId': 'NCT01174667', 'briefTitle': 'Massage of the Low Back Muscles Assessed With Ultrasound Scanning', 'organization': {'class': 'OTHER', 'fullName': 'Anglo-European College of Chiropractic'}, 'officialTitle': 'Effect of Fascial Release on Connective Tissue Structure in Human Subjects With Chronic Low Back Pain as Determined by Ultrasound Imaging: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'AECC 290710'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fascial massage', 'description': 'A specific type of fascial massage to release restricted lumbodorsal fascia.', 'interventionNames': ['Procedure: Specific massage for fascial release']}, {'type': 'NO_INTERVENTION', 'label': 'No treatment control', 'description': 'Patient will rest quietly without receiving any instruction.', 'interventionNames': ['Other: Quiet non-instructed rest for 3 minutes']}], 'interventions': [{'name': 'Specific massage for fascial release', 'type': 'PROCEDURE', 'otherNames': ['Superficial fascial release'], 'description': 'Patient will receive a 3 minute massage to reduce restrictions in the lumbodorsal fascia.', 'armGroupLabels': ['Fascial massage']}, {'name': 'Quiet non-instructed rest for 3 minutes', 'type': 'OTHER', 'otherNames': ['Uninstructed rest'], 'description': 'Patient will lay quietly without any instructions on how to relax.', 'armGroupLabels': ['No treatment control']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hugh Gemmell, DC, EdD', 'role': 'CONTACT', 'email': 'hgemmell@aecc.ac.uk', 'phone': '441202436268', 'phoneExt': '268'}, {'name': 'Jane Cook, DC, MSc', 'role': 'CONTACT', 'email': 'janecook@aecc.ac.uk', 'phone': '441202436200', 'phoneExt': '208'}], 'overallOfficials': [{'name': 'Hugh Gemmell, DC, EdD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anglo-European College of Chiropractic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anglo-European College of Chiropractic', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Hugh Gemmell Principal Lecturer', 'oldOrganization': 'Anglo-European College of Chiropractic'}}}}